drugset / Trial / NCT01691755

A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

NCT01691755 ↗

Phase 3 Completed 196 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.

Timeline

Start
2012-11
Primary completion
2013-09
Completion
2013-09

Outcome

Met primary endpoint

paper Reductions in HbA1c concentration from baseline to week 26 were statistically significantly greater with aleglitazar than with placebo. PMID 25728612 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject aleglitazar Small molecule 150 ug Oral